Congress Abstracts 2003

91

GLEEVEC™ TREATMENT FOR CHRONIC MYELOID LEUKEMIA: THE NURSING MANAGEMENT CHALLENGE FROM CLINICAL TRIALS TO THE PRESENT. Suzanne Chanel, RN, OCN^®, Farah Hossain, MA, and Janice Reid, RN, MA, OCN^®, Memorial Sloan-Kettering Cancer Center, New York, NY.

Gleevec, (formerly STI-571), a novel oral tyrosine kinase inhibitor, was granted FDA approval in May 2001 for use in patients with chronic myelogenous leukemia (CML). CML is a hematologic stem cell malignancy, characterized cytogenetically by a chromosomal translocation known as the Philadelphia Chromosome, which consequently expresses the bcr-abl tyrosine kinase; an abnormal protein, giving rise to this form of myeloid leukemia. CML progresses through three distinctive phases: chronic, accelerated, and blastic disease. Historically, the vanguard therapy approaches have been Interferon-alpha, Cytarabine (Ara-C), and allogeneic bone marrow transplantation. This NCI-designated comprehensive cancer center participated in an international, multicenter trial, preceding the licensure of Gleevec, comprised of patients with either chronic or accelerated phase disease. Efficacy data derived from this collaborative study continues to undergo analyses. To date, interim results of such trials have demonstrated durable hematologic and cytogenetic responses. However, early in the trial, it was apparent that this therapy would present significant challenges to nursing management. The understanding of Gleevec, as it pertains to safety and toxicity, is a consistently evolving process with frequent emergence of new information. Most notable, is Gleevec’s potential drug interaction profile. Gleevec and numerous drug classifications share a common metabolism via the CYP3A4 isoenzyme system, thus, potentially inhibiting or synergizing the effects of either Gleevec or the concomitant medication(s). Such drug interactions are potentially life threatening. Case reports have demonstrated serious sequelae resultant from these interactions. Gleevec has a modest toxicity profile, lacks the myeloablative side effects of standardized therapies, hence preserving and enhancing quality of life. This has dramatically altered the landscape of CML management and outcomes.

This presentation will delineate the complex patient care management issues experienced during the course of these clinical trials. Methodologies of patient monitoring, preventative strategies, patient education, and the standard of care for patients receiving Gleevec at this institution will be illustrated.